Overview
Humanized IgG1 Mab that binds to the human interleukin-2 receptor (anti-Tac or anti-CD25). Daclizumab is a composite of human (90%) and murine (10%) antibody sequences. The human sequences were derived from the constant domains of human IgG1 and the variable framework regions of the Eu myeloma antibody. The murine sequences were derived from the complementarity-determining regions of a murine anti-Tac antibody. On 22 April 2008, Roche Registration Limited chose to voluntarily withdraw the marketing authorization for their product Zenapax (daclizumab), as indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation and used concomitantly with an immunosuppressive regimen like cyclosporine and corticosteroids in patients who are not hight immunized, for commercial reasons and confirmed that this decision was not related to any safety concerns associated with the use of Zenapax (daclizumab) . Regardless of the withdrawal of Zenapax, Biogen and Abbvie's Zinbryta (daclizumab), as indicated for the treatment of adult patients with relapsing forms of multiple sclerosis, was approved for use by the FDA in 2016 . Despite being approved for use, Zinbryta (daclizumab)'s complex pre-existing safety profile consisting of its restricted availability through a Risk Evaluation and Mitigation Strategy program and its black box warning for possible hepatic injury, autoimmune hepatitis, and other immune mediated disorders meant its therapeutic usage, adverse effects, and prescribing information was subject to continuous monitoring and updating. Although Zinbryta (daclizumab) was available for patients as needed until 30 April 2018, Biogen and Abbvie announced a voluntary withdrawal of their product Zinbryta (daclizumab) from the global market on 2 March 2018 . This withdrawal was concurrent to the European Medicines Agency announcement of a recall owing to 12 worldwide reports of serious inflammatory brain disorders associated with the use of Zinbryta (daclizumab) .
Indication
Zenapax is a humanized monoclonal antibody used for prevention of renal transplant rejection
Associated Conditions
- Relapsing Multiple Sclerosis (RMS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2016/08/29 | Phase 3 | Terminated | |||
2016/02/19 | Phase 3 | Completed | |||
2015/10/15 | Phase 4 | Completed | |||
2015/09/18 | Phase 4 | Completed | |||
2010/07/29 | Phase 4 | Completed | |||
2010/02/08 | Phase 3 | Completed | |||
2009/03/10 | Not Applicable | Completed | |||
2009/02/19 | Phase 1 | Completed | |||
2008/11/13 | Phase 2 | Withdrawn | |||
2008/05/28 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ZINBRYTA | Biogen Canada Inc | 02459639 | Solution - Subcutaneous | 150 MG / ML | N/A |
ZENAPAX 5MG/ML | Hoffmann-La Roche Limited | 02241473 | Liquid - Intravenous | 5 MG / ML | 3/2/2000 |
ZINBRYTA | Biogen Canada Inc | 02459620 | Solution - Subcutaneous | 150 MG / ML | 3/30/2017 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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